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The FDA’s Digital Health Advisory Committee (DHAC) will meet Thursday to discuss how to regulate and mitigate the risks involved with new devices and forms of therapy that use AI. And in Ohio, lawmakers have proposed fines for companies whose chatbots promote self-harm. Stat: FDA Digital Advisers To Confront Risks Of Therapy Chatbots A Food and Drug Administration advisory committee will meet Thursday to explore a topic that’s been taboo during the Trump administration: Regulating artificial intelligence. (Aguilar, 11/5) Cleveland.com: Lawmakers Want Ohio To Penalize AI Companies When Chatbots Promote Self-Harm Any money collected would go to the 988 Suicide and Crisis Lifeline Fund, which supports mental health crisis response services across Ohio. (Staver, 11/4) The New York Times: The Editor Got A Letter From ‘Dr. B.S.’ So Did A Lot Of Other Editors Letters to the editor from writers using chatbots are flooding the world’s scientific journals, according to new research and journal editors. The practice is putting at risk a part of scientific publishing that editors say is needed to sharpen research findings and create new directions for inquiry. A new study on the problem started with a tropical disease specialist who had a weird experience with a chatbot-written letter. He decided to figure out just what was going on and who was submitting all those letters. (Kolata, 11/4) More on the FDA — Politico: White House Backs FDA Head After Ouster Of Top Regulator The White House is rallying behind Food and Drug Administration Commissioner Marty Makary after the abrupt ousting of one of his top deputies over the weekend, the latest tumult in an agency that’s seen plenty this year. A new top drug regulator will likely be installed on Wednesday to replace George Tidmarsh as director of the FDA’s Center for Drug Evaluation and Research, according to a Health and Human Services official granted anonymity to discuss personnel planning. (Lim and Gardner, 11/4) More pharmaceutical developments — Stat: Biomedical Institute Arena BioWorks Is Shutting Down Arena BioWorks, the buzzy research institute that launched nearly two years ago with $500 million to support a decade of scientific R&D, is abruptly shutting down, the institute confirmed to STAT. (DeAngelis and Mast, 11/4) Newsweek: Cancer Drug Made 20,000 Times More Potent In Breakthrough A common cancer drug has been restructured to make its cancer cell killing abilities up to 20,000 times more effective while also reducing its toxicity. Researchers from the Northwestern University in Illinois re-engineered the structure of the commonly-used chemotherapy drug 5-fluorouracil (5FU) into that of a "spherical nucleic acid" (SNA)—a nanostructure that weaves the drug directly into DNA strands coating tiny spheres. Such makes it far more powerful and targeted—leaving healthy cells unharmed. (Millington, 11/4) CIDRAP: Trial Data Show Ensitrelvir Has Potent Antiviral Activity Against COVID-19 Data from a phase 2 randomized controlled clinical trial indicate that the antiviral drug ensitrelvir is an effective alternative to other COVID-19 antiviral treatments, researchers reported last month in The Lancet Infectious Diseases. The once-daily oral drug, a SARS-CoV-2 main protease inhibitor developed by Shionogi, is registered in Japan and Singapore for treating COVID-19. It has been given to more than 1 million people but is an investigative drug outside those countries and has not been compared with other COVID antivirals. (Dall, 11/4) MedPage Today: FDA Approves IV Antibiotic For Complicated UTIs The FDA approved an intravenous (IV) formulation of fosfomycin (Contepo) to treat adults with complicated urinary tract infection (cUTI), including acute pyelonephritis, caused by susceptible Escherichia coli and Klebsiella pneumoniae, Meitheal Pharmaceuticals announced. Fosfomycin is an injectable epoxide and sole antibiotic class member with no known cross-resistance to other antibiotic classes. It has demonstrated activity against gram-negative bacteria and other antimicrobial resistant pathogens, the company said. (Rudd, 11/4) Becker's Hospital Review: 14 Drugs In Shortage Here are 14 recent drug shortages and discontinuations, according to FDA drug supply databases: Acetaminophen; oxycodone hydrochloride tablet: Multiple strengths of Percocet were discontinued Nov. 3 due to the end of manufacturing. (Jeffries, 11/4) This is part of the Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.
